Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy

N/ACompletedNCT02037958

Changi General Hospital76 enrolled

Overview

We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.

The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

Conditions

Cholecystitis Choledocholithiasis

Interventions

Laryngeal Mask Airway-SupremeDEVICE

Patients who receive the LMA-S

Endotracheal TubeDEVICE

Patients who receive endotracheal intubation

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiologists (ASA) Physical Status 1 and 2 * Undergoing elective laparoscopic cholecystectomy Exclusion Criteria: * BMI \> 30 * Known gastro-oesophageal reflux disease * predicted or documented difficult airway * contraindications to drugs in the standardized anaesthesia protocol

Locations (1)

Changi General Hospital

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

Time to Effective Airway

Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation

Time frame: Baseline

Secondary Outcomes

Number of attempts taken for successful placement of airway device

Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned

Time frame: Baseline

Number of attempts taken for successful placement of gastric tube

Number of attempts needed for successful placement of gastric tube. Correct gastric tube placement was determined by positive suctioning of gastric contents or detection of injected air with epigastric auscultation.

Time frame: Baseline

Haemodynamic response to insertion of airway device

Systolic blood pressure and heart rate at 0 min, 1 min, 5 min, starting from the time the face mask was removed from the patient's face.

Time frame: Baseline, 1 min, 5 min

Peak airway pressure during pneumoperitoneum

Peak airway pressure recorded during pneumoperitoneum, measured during the surgery

Time frame: Assessed intra-operatively, during the period of pneumoperitoneum

Incidence of post-operative sore throat

Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr after the end of surgery. No further follow-up.

Time frame: Assessed 1 hr after the surgery, at the Recovery Area

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.